ArticleJournal of neurointerventional surgery2022
Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial.
Article in Journal of neurointerventional surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01801007 (Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable: A Systematic Review and Meta-Analysis.JAMA network open · 2023Pooled it
- Impact of branch arteries on efficacy of endoluminal flow diverters: Insights from posterior communicating artery aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Review
- Comparison of pipeline embolization device, flow re-direction endoluminal device and surpass flow diverters in the treatment of intracerebral aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Article
- Endovascular Treatment of Ruptured and Unruptured Wide-Neck Intracranial Aneurysms Using LVIS EVO Stent-Assisted Coiling: Mid-Term Results.Journal of clinical medicine · 2025Article
- Largest documented cerebral aneurysm mimicking a giant brain tumor and treated by highly selective occlusion of inflow: illustrative case.Journal of neurosurgery. Case lessons · 2025Article
- Treatment of Intracranial Aneurysms with the FRED X Flow Diverter Stent: Mid-term Angiographic and Safety Results.Clinical neuroradiology · 2025Article
- The FRED-X Flow Diverter-An Australian Experience.Journal of medical imaging and radiation oncology · 2025Article
- The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study.Scientific reports · 2025Observational
- Multicenter analysis of the incidence of in-stent stenosis following the deployment of flow-redirection endoluminal device in the treatment of intracranial aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Successful Flow Diversion for a Giant Anterior Cerebral Artery Aneurysm Using the Flow-Redirection Endoluminal Device (FRED).Journal of neuroendovascular therapy · 2025Article
- Comparison of Flow Reduction Efficacy of Nominal and Oversized Flow Diverters Using a Novel Measurement-assisted in Silico Method.Clinical neuroradiology · 2024Article
- Flow Diversion for Endovascular Treatment of Intracranial Aneurysms: Past, Present, and Future Directions.Journal of clinical medicine · 2024Review
- Review
- Factors influencing early obliteration during flow diverter treatment of cerebral aneurysms: Establishment of an early obliteration inhibition score.Fujita medical journal · 2023Article
- Acute Intraprocedural Thrombosis After Flow Diverter Stent Implantation: Risk Factors and Relevance of Standard Observation Time for Early Detection and Management.Clinical neuroradiology · 2023Article
- The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology-First Multicenter Experience in 161 Patients.AJNR. American journal of neuroradiology · 2023Article
- Flow Diverter Performance for the Treatment of Intracranial Aneurysms: An International Multicenter Comparative Study.Stroke (Hoboken, N.J.) · 2023Article
- Delayed aneurysm rupture in a patient treated with flow redirection endoluminal device: A case report and literature review.Surgical neurology international · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
objectiveTo evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.
methods145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.
results145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%)
conclusionAs compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms. CLINICAL REGISTRATION NUMBER: NCT01801007.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.